Abstract
BackgroundTreatment with disease-modifying anti-rheumatic drugs (DMARDs) has raised concerns about the risk of malignancies in rheumatoid arthritis (RA) patients. However, the association between biologic DMARDs (bDMARDs) and malignancy in previous reports remains controversial. Therefore we aimed to estimate the incidence of malignancy in early RA patients and to evaluate the relative risk of malignancy with use of bDMARDs.MethodsA retrospective cohort of incident RA patients was established using the Korean National Claims Database. Among a total of 14,081 RA patients identified, 1684 patients with a history of malignancy were excluded. We calculated the incidence rate of overall and individual malignancies. The standardized incidence ratio (SIR) of malignancies in bDMARD users was compared to that in nonusers. Multivariable logistic regression analysis was used to evaluate the impact of bDMARDs on the development of malignancies in early RA patients.ResultsA total of 12,397 early RA patients without a history of malignancy were enrolled. During 41,599 person-years (PY) of follow-up, 725 malignancies developed in 561 patients (174.3/10,000 PY) and 21 hematologic malignancies developed (5.0/10,000 PY). Patients treated with bDMARDs had a significantly lower incidence of overall malignancy compared to those not treated with bDMARDs (SIR 0.45 (95% CI 0.28–0.70)). However, this relationship was not significant with regard to hematologic malignancies (SIR 2.65 (95% CI 0.55–7.76)). On multivariable analysis, bDMARD use was a protective factor against the development of overall malignancy (odds ratio 0.42 (95% CI 0.25–0.73)). However, bDMARD use had no significant protective effect against the development of hematologic malignancies (odds ratio 1.69 (95% CI 0.38–7.59)).ConclusionsIn early RA patients, bDMARD use decreases the overall risk of developing malignancies; however, it does not affect the risk of developing hematologic malignancies.
Highlights
Treatment with disease-modifying anti-rheumatic drugs (DMARDs) has raised concerns about the risk of malignancies in rheumatoid arthritis (RA) patients
A recent meta-analysis of randomized trials found that treatment with Tumor necrosis factor (TNF) inhibitors was associated with a 2–3.3-fold elevated risk of malignancy compared to non-TNF inhibitor therapies [11, 12]
Data source An inception cohort of early RA patients was built based on the Health Insurance Review and Assessment (HIRA) database of South Korea
Summary
Treatment with disease-modifying anti-rheumatic drugs (DMARDs) has raised concerns about the risk of malignancies in rheumatoid arthritis (RA) patients. We aimed to estimate the incidence of malignancy in early RA patients and to evaluate the relative risk of malignancy with use of bDMARDs. Patients with rheumatoid arthritis (RA) are at increased risk of developing certain malignancies, including lymphoma, leukemia, and lung cancer [1,2,3]. Patients with rheumatoid arthritis (RA) are at increased risk of developing certain malignancies, including lymphoma, leukemia, and lung cancer [1,2,3] This predisposition for malignancy is attributed to the immune dysregulation and/or chronic inflammation in RA, which increases cell proliferation, mutagenesis, oncogene activation, and angiogenesis [4]. A recent meta-analysis of randomized trials found that treatment with TNF inhibitors was associated with a 2–3.3-fold elevated risk of malignancy compared to non-TNF inhibitor therapies [11, 12]. Recent postmarketing surveillance found that treatment with tocilizumab did not increase the risk of malignancy in RA patients [19]
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